1 Boring Old Man

Vanessa’s Law Honours Memory Of Tory MP Terence Young’s Late Daughter

Huffington Post

By The Canadian Press

12/06/2013

The Conservative government has introduced new legislation aimed at protecting consumers from unsafe medications and reducing adverse drug reactions. The Protecting Canadians from Unsafe Drugs Act is known as Vanessa’s Law in honour of the late daughter of Conservative MP Terence Young. The 15-year-old died of a heart attack 13 years ago while on a prescription drug for a stomach ailment. The medication was later deemed unsafe and pulled from the market.

Young, MP for Oakville, has been fighting ever since for a more stringent Canadian drug-monitoring system. Under the new legislation, the government now has the power to initiate mandatory recalls for unsafe drugs and to demand reports from health-care institutions on adverse drug reactions. The bill also allows the government to impose tough new penalties for unsafe products, including jail time and new fines of up to $5 million a day instead of the current $5,000.

Drug companies must also revise labelling to provide details on health risks, and to do further testing on medications when they are shown to pose dangers to some consumers, especially children.

Minister Ambrose announces a Transparency and Openness Framework

Health Canada posts Diane-35 Safety Review Summary and works with partners on a prescriber checklist as first step

CNW

from Health Canada

04/08/2014

The Honourable Rona Ambrose, Minister of Health, today delivered on a commitment to begin transparently publishing drug safety reviews. The Minister committed to providing Canadians with access to Health Canada drug safety reviews with the posting of a summary of the safety review of the acne treatment Diane-35. This is the first summary safety review to be made public.

Once a drug is on the Canadian market, Health Canada continues to monitor the safety of health products to identify and assess potential harms. As a result, departmental safety reviews are conducted when a safety issue is identified for a product on the Canadian market. The posting of summary safety reviews will provide Canadians with plain-language descriptions of Health Canada’s findings and decisions, so patients can make informed decisions and continue to have confidence in the health products they use. The full reports will be made available through a link on Health Canada’s website; however they are subject to redactions of personal and confidential information.

The posting of summary safety reviews is the first in a series of measures that Health Canada is taking to be more transparent and open with Canadians about regulatory decisions. As part of Health Canada’s Regulatory Transparency and Openness Framework, the department has committed to providing Canadians with credible and timely information. This easy to understand information will allow them to make well-informed decisions concerning their health and that of their families. Canadians will also have the chance to provide Health Canada with feedback on the Framework.

Health Canada has also made available today a practical new tool to assist in the safe prescribing of Diane-35 and to better inform healthcare professionals and patients of its risks. In consultation with the Canadian Pharmacists Association, the Canadian Dermatology Association, and the Institute for Safe Medication Practices, Health Canada has developed a checklist to guide healthcare professionals through the decision to prescribe Diane-35. The checklist will reinforce existing warnings and precautions for this drug.

Today’s announcements build on the Government’s Patient Safety agenda, including Legislation that was introduced in December 2013, known as the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law).

House of Commons adopts government strengthened patient safety legislation

Amended Vanessa’s Law advances transparency commitments

Digital Journal

by Canada NewsWire

June 16, 2014

The Government of Canada welcomes amendments that would strengthen transparency in the proposed patient safety legislation Vanessa’s Law [Bill C-17]. Since introduction in December 2013, Vanessa’s Law has received broad support from members of Parliament, stakeholders and healthcare groups in recognition of the important drug safety improvements that it would deliver, should it become law.

The amendments to Bill C-17 were introduced by Member of Parliament, Terrence Young and adopted by the House of Commons Standing Committee on Health on June 12. The Bill has now passed Third Reading in the House of Commons and moves to the Senate for consideration. The amendments include the requirement that both positive and negative decisions about drug authorizations be disclosed on a public website; and that clinical trial information be disclosed on a public registry. The amendments also better define the scope of confidential business information [CBI] and allow the Minister to disclose CBI about a product if the Minister believes the product may pose a serious risk to Canadians.

The amendments to Bill C-17 would enable Health Canada to continue strengthening its Regulatory Transparency and Openness Framework that was announced in April of this year by the Minister. The Framework commits Health Canada to a set of concrete initiatives that would make easy to understand regulatory health and safety information more available to Canadians. With this information, Canadians can make well-informed decisions concerning their health and that of their families.

Quick Facts

• Vanessa’s Law [Bill C-17] would give the Minister of Health new tools to better respond to drug safety issues, such as the power to recall unsafe drugs, impose stiff financial penalties, and require mandatory adverse reaction reporting by healthcare facilities.
• The amendments to the Bill would enhance transparency concerning Health Canada’s regulatory decisions, information regarding clinical trials, and the scope of confidential business information and disclosure.
• If passed, Vanessa’s Law would provide new tools to make pharmaceutical drugs, biologics and medical devices safer for Canadians.

Quotes

• Vanessa’s Law would enable us to take drug safety to a new level. With the amendments brought forward by my colleague Terence Young, it would now also provide Canadian patients and safety experts with information they have long been calling for. I will also personally ensure that Health Canada continues to find ways to be more open and more transparent with Canadians each and every year. I’ve made that commitment. We will be looking at further steps to ensure that crucial drug safety information is made available to Canadians."
  Rona Ambrose – Minister of Health
• "Once implemented, Vanessa’s Law will save innumerable of lives a year in Canada, and prevent tens of thousands of injuries. It is difficult to overstate the importance of this Bill to patient safety. This is a generational change. Vanessa would be very pleased to know that her loss of life has led to the government of Canada acting to prevent others from suffering her fate."
  Terence Young – Member of Parliament

Unless I’ve misread this story, it’s aiming towards being a model for us all. The details of the Data Transparency scheme aren’t completely apparent, but the progression of their march is encouraging and with a track record like this, one would predict that even if they falter on the details, they’ll get things right sooner or later [if I’m wrong about that, I hope some of our neighbors in Canada will let me know]. I particularly like the idea of posting the public summaries. I hope the specifics live up to my optimism…